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Champion Industries, Inc.

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Overview Company News Filings

South Korean Markets Decline as Investors Book Profits Amid Acting President Step-In

MT Newswires Live

European Medicines Agency's Human Use Committee Backs Approval for Celltrion Biosimilars

MT Newswires Live

NVO Gets Positive CHMP Opinion in EU for Ozempic Expanded Use in CKD

Merck announces CHMP opinion recommending conditional approval of Welireg

BRIEF-Gilead’S Seladelpar Receives Positive CHMP Opinion For Primary Biliary Cholangitis

Geron announces positive CHMP opinion for Rytelo

Gilead announces positive CHMP opinion for seladelpar

Gilead’s Seladelpar Receives Positive CHMP Opinion for Primary Biliary Cholangitis

Geron Announces Positive CHMP Opinion for RYTELO™ (imetelstat) for the Treatment of Adults with Transfusion-Dependent Anemia due to Lower-Risk MDS

CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union

Positive Outlook for Formycon AG: CHMP Approval and Strategic Market Positioning Reinforce Buy Rating

CHMP Endorses AstraZeneca's Tagrisso for Expanded Use in NSCLC

AbbVie's Ovarian Cancer Drug Elahere Gets Approval in Europe

CHMP Endorses J&J's Rybrevant-Lazcluze Combo for Use in NSCLC

AstraZeneca’s Tagrisso recommended for approval in EU by CHMP for certain NSCLC

Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe

BRIEF-Bristol Myers Squibb Receives Positive CHMP Opinion For Opdivo (Nivolumab) Plus Yervoy (Ipilimumab) For The First-Line Treatment Of Adult Patients With Microsatellite Instability–High Or Mismatch Repair Deficient Metastatic Colorectal Cancer

InflaRx receives positive CHMP opinion for GOHIBIC for SARS-CoV-2-induced ARDS

Merck Gets CHMP Backing of Keytruda in Malignant Pleural Mesothelioma

InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome

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Markets eagerly waited for the political scenario to unfold further, as acting ","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["CHMP","BK4087","ISBC","BK4211"],"gpt_icon":0},{"id":"2491683416","title":"European Medicines Agency's Human Use Committee Backs Approval for Celltrion Biosimilars","url":"https://stock-news.laohu8.com/highlight/detail?id=2491683416","media":"MT Newswires Live","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2491683416?lang=en_us&edition=fundamental","pubTime":"2024-12-16 09:06","pubTimestamp":1734311214,"startTime":"0","endTime":"0","summary":"The European Medicines Agency's Committee for Medicinal Products for Human Use  issued positive opinions for Celltrion's  biosimilars Eydenzelt , Stoboclo and Osenvelt , and Avtozma , Celltrion said Monday.Eydenzelt, comparable to Eylea, targets retinal disorders such as wet AMD and diabetic macular edema. Stoboclo and Osenvelt are at par with Prolia and Xgeva for osteoporosis and cancer-related conditions. Avtozma is comparable to RoActemra for rheumatoid arthritis and other inflammatory diseases, the press release said.The products require European Commission approval for marketing in the European Union.Shares of Celltrion rose more than 1% in recent trade on Monday.","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["LU1852331112.SGD","LU1923623000.USD","BK4534","BK4512","LU0390134368.USD","LU0719512351.SGD","LU2458330169.SGD","LU0127658192.USD","BK4566","LU0823434740.USD","LU2054465674.USD","LU0056508442.USD","LU1951200564.SGD","BK4585","BK4575","LU1064131342.USD","LU1880398471.USD","IE00BMPRXN33.USD","LU0823421333.USD","IE0009356076.USD","LU2458330243.SGD","LU0979878070.USD","IE00BMPRXR70.SGD","LU1988902786.USD","LU0082616367.USD","IE00B5949003.HKD","LU2098885051.SGD","BK4573","MDCO","BK4554","LU0081259029.USD","LU0823434583.USD","LU1242518857.USD","CHMP","LU1951198990.SGD","LU0109392836.USD","LU2264538146.SGD","LU1303367103.USD","BK4529","LU2250418816.HKD","LU1316542783.SGD","BK4588","BK4087","BK4141","LU0889565833.HKD","LU0642271901.SGD","LU1803068979.SGD","LU1880398554.USD","LU0198837287.USD"],"gpt_icon":1},{"id":"2491537299","title":"NVO Gets Positive CHMP Opinion in EU for Ozempic Expanded Use in CKD","url":"https://stock-news.laohu8.com/highlight/detail?id=2491537299","media":"Zacks","labels":["executive"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2491537299?lang=en_us&edition=fundamental","pubTime":"2024-12-13 21:48","pubTimestamp":1734097680,"startTime":"0","endTime":"0","summary":"Novo NordiskNVO announced that the Committee for Medicinal Products for Human Use  of the European Medicines Agency  has adopted a positive opinion recommending the label expansion of Ozempic  to treat patients with type II diabetes  and chronic kidney disease  in the EU. Subject to approval, the drug will be indicated as an adjunct to the standard of care for the prevention of the progression of renal impairment in T2D and CKD patients. A final decision from EMA is expected soon.Please note that Novo Nordisk’s once-weekly subcutaneous diabetes injection, Ozempic, is already approved in 0.25 mg, 0.5 mg, 1 mg and 2 mg doses for treating T2D mellitus in adults, adjunct to diet and exercise. Ozempic is also approved for reducing the risk of major adverse cardiovascular events in adults with T2D mellitus and established cardiovascular disease.The recommendation from the CHMP was based on positive results from Novo Nordisk’s FLOW outcomes study, which achieved its primary endpoint of a supe","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/EaYjwqFOUx_QJeP7FQN8Aw--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/723b414aa10600faf58f7a232ec73364","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/EaYjwqFOUx_QJeP7FQN8Aw--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/723b414aa10600faf58f7a232ec73364"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/nvo-gets-positive-chmp-opinion-134800017.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"executive","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4196","BK4585","BK4007","CHMP","LU1093756168.USD","CSTL","LU0154236417.USD","IE00BKVL7J92.USD","BK4139","NVO","BK4156","BK4588","SPRO","CTMX","IE00BZ1G4Q59.USD","BK4599","LU1093756325.SGD","BK4532","BK4087"],"gpt_icon":0},{"id":"2491321399","title":"Merck announces CHMP opinion recommending conditional approval of Welireg","url":"https://stock-news.laohu8.com/highlight/detail?id=2491321399","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2491321399?lang=en_us&edition=fundamental","pubTime":"2024-12-13 20:10","pubTimestamp":1734091840,"startTime":"0","endTime":"0","summary":"Merck (MRK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, adopted an opinion recommending...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/merck-announces-chmp-opinion-recommending-conditional-approval-of-welireg?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/merck-announces-chmp-opinion-recommending-conditional-approval-of-welireg?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["LU0203347892.USD","IE0002141913.USD","LU2361044949.HKD","LU1037948541.HKD","MRK","LU1934455863.HKD","LU0965508806.USD","SG9999002232.USD","IE00B1BXHZ80.USD","LU0058720904.USD","LU0070302665.USD","LU1974910355.USD","LU0289739699.SGD","CHMP","SG9999001176.USD","BK4550","LU1430594728.SGD","LU2106854487.HKD","LU1983299246.USD","BK4007","LU1066053197.SGD","LU2468319806.SGD","LU1057294990.SGD","BK4559","IE00BJT1NW94.SGD","SG9999014559.SGD","LU2023250843.SGD","BK4087","LU1116320901.HKD","LU0266013472.USD","LU2361044865.SGD","LU1061106388.HKD","LU2461242641.AUD","LU2324357040.USD","LU0985320562.USD","LU0203345920.USD","LU0006306889.USD","LU0265550359.USD","LU1941712264.USD","SG9999014575.USD","IE00BLSP4452.SGD","LU1066051498.USD","LU1699723380.USD","LU1116320737.USD","LU0320765489.SGD","LU2089984988.USD","LU0265550946.USD","SGXZ57979304.SGD","LU1917777945.USD","SG9999015358.SGD"],"gpt_icon":0},{"id":"2491329381","title":"BRIEF-Gilead’S Seladelpar Receives Positive CHMP Opinion For Primary Biliary Cholangitis","url":"https://stock-news.laohu8.com/highlight/detail?id=2491329381","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2491329381?lang=en_us&edition=fundamental","pubTime":"2024-12-13 19:57","pubTimestamp":1734091048,"startTime":"0","endTime":"0","summary":"Dec 13 (Reuters) - Gilead Sciences Inc   :   * GILEAD’S SELADELPAR RECEIVES POSITIVE CHMP OPINION FOR PRIMARY BILIARY CHOLANGITIS   * GILEAD: FINAL EUROPEAN COMMISSION DECISION IS ANTICIPATED IN Q1 OF 2025Source text:    Further company coverage:    ((Reuters.Briefs@thomsonreuters.com;))","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.rkd.refinitiv.com/api/News/News.svc/REST/News_1/RetrieveStoryML_1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4585","CHMP","BK4583","IE00BSNM7G36.USD","LU1585245621.USD","LU1839511570.USD","IE00B19Z3581.USD","BK4566","LU1066051498.USD","LU2087621335.USD","IE00B19Z3B42.SGD","LU0289739699.SGD","IE00BKVL7J92.USD","BK4139","BK4578","LU0234570918.USD","LU0320765992.SGD","IE00B7SZLL34.SGD","LU0058720904.USD","IE0002270589.USD","BK4588","GILD","LU2468319806.SGD","BK4568","IE00BZ1G4Q59.USD","BK4550","IE00B3T34201.USD","BK4532","LU0109394709.USD","LU1066053197.SGD","BK4087","LU1430594728.SGD","LU0889565916.HKD","LU1571399168.USD"],"gpt_icon":0},{"id":"2491260353","title":"Geron announces positive CHMP opinion for Rytelo","url":"https://stock-news.laohu8.com/highlight/detail?id=2491260353","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2491260353?lang=en_us&edition=fundamental","pubTime":"2024-12-13 19:40","pubTimestamp":1734090027,"startTime":"0","endTime":"0","summary":"Geron (GERN) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion reco...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/geron-announces-positive-chmp-opinion-for-rytelo?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/geron-announces-positive-chmp-opinion-for-rytelo?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["GERN","BK4139","CHMP","BK4087"],"gpt_icon":0},{"id":"2491326089","title":"Gilead announces positive CHMP opinion for seladelpar","url":"https://stock-news.laohu8.com/highlight/detail?id=2491326089","media":"TIPRANKS","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2491326089?lang=en_us&edition=fundamental","pubTime":"2024-12-13 19:40","pubTimestamp":1734090008,"startTime":"0","endTime":"0","summary":"Gilead (GILD) Sciences announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinio...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/gilead-announces-positive-chmp-opinion-for-seladelpar?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/gilead-announces-positive-chmp-opinion-for-seladelpar?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4583","LU0320765992.SGD","IE00B19Z3581.USD","BK4588","IE00BKVL7J92.USD","IE00B7SZLL34.SGD","LU0109394709.USD","BK4139","BK4578","BK4566","IE0002270589.USD","IE00B19Z3B42.SGD","BK4550","LU0234570918.USD","LU2087621335.USD","IE00BZ1G4Q59.USD","LU1066051498.USD","LU1571399168.USD","LU0058720904.USD","IE00BSNM7G36.USD","LU1839511570.USD","BK4087","BK4585","BK4532","LU0289739699.SGD","LU0889565916.HKD","GILD","IE00B3T34201.USD","LU2468319806.SGD","LU1585245621.USD","BK4568","LU1430594728.SGD","CHMP","LU1066053197.SGD"],"gpt_icon":0},{"id":"2491214753","title":"Gilead’s Seladelpar Receives Positive CHMP Opinion for Primary Biliary Cholangitis","url":"https://stock-news.laohu8.com/highlight/detail?id=2491214753","media":"Business Wire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2491214753?lang=en_us&edition=fundamental","pubTime":"2024-12-13 19:37","pubTimestamp":1734089820,"startTime":"0","endTime":"0","summary":"– Recommendation Based on the RESPONSE Study Which Demonstrated ALP Normalization in 25% of Participants at 12 Months and Statistically Significant Reduction of Pruritus Versus Placebo –。The positive opinion was supported primarily by data from the pivotal placebo-controlled Phase 3 RESPONSE study. In the study, 62% of participants taking seladelpar achieved the primary endpoint of composite biochemical response at month 12 compared with 20% of participants taking placebo. Treatment with seladelpar led to normalization of ALP values in 25% of trial participants at month 12. This change was not seen in any trial participants receiving placebo. ALP is a cholestatic marker that is a predictor of risk for liver transplant and death. Change from baseline pruritus score at month 6 was a key s","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/pvxf9aCo6mke7xm8sJZyWg--~B/aD01NzY7dz0xNzI4O2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/business-wire.com/86a7735b21854a533ac901b334cc91fe","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/pvxf9aCo6mke7xm8sJZyWg--~B/aD01NzY7dz0xNzI4O2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/business-wire.com/86a7735b21854a533ac901b334cc91fe"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/gilead-seladelpar-receives-positive-chmp-113700996.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["GILD","CHMP","BK4568","BK4528","BK4139","LU1571399168.USD","LU2468319806.SGD","PBC","IE00B19Z3581.USD","LU0058720904.USD","LU1839511570.USD","GGT","BK4205","LU0109394709.USD","LU2087621335.USD","BK4599","LU0289739699.SGD","BK4233","BK4087","IE00BZ1G4Q59.USD","IE00BKVL7J92.USD","IE00BSNM7G36.USD","LU1878469433.USD","IE00B19Z3B42.SGD","BK4566","IE00B7SZLL34.SGD","LU0889565916.HKD","LU1430594728.SGD","BK4588","BK4585","IE0002270589.USD","LU0320765992.SGD","LU0234570918.USD","UK","IE00B3T34201.USD","LU1066053197.SGD","LU1585245621.USD","LU1066051498.USD","BK4583","ALT","BK4532","BK4550","BK4578"],"gpt_icon":0},{"id":"2491327214","title":"Geron Announces Positive CHMP Opinion for RYTELO™ (imetelstat) for the Treatment of Adults with Transfusion-Dependent Anemia due to Lower-Risk MDS","url":"https://stock-news.laohu8.com/highlight/detail?id=2491327214","media":"Business Wire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2491327214?lang=en_us&edition=fundamental","pubTime":"2024-12-13 19:36","pubTimestamp":1734089760,"startTime":"0","endTime":"0","summary":"FOSTER CITY, Calif., December 13, 2024----Geron Corporation , a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced that the Committee for Medicinal Products for Human Use  of the European Medicines Agency  has adopted a positive opinion recommending the approval of RYTELO  for the treatment of adult patients with transfusion-dependent  anemia due to very low, low or intermediate risk myelodysplastic syndromes  without an isolated deletion 5q cytogenetic  abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. The European Commission , which has the authority to approve medicines in the European Union , will review the CHMP’s recommendation and is expected to make a final decision on the marketing authorization application  in the following months.Lower-risk myelodysplastic syndromes  is a blood cancer that often progresses to require increasingly intensified manageme","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/3xXvPBJ2NJ_uZgG.c_zzOQ--~B/aD01MTI7dz0xMDI0O2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/business-wire.com/3912c5832ea4ed32855cb10e0d53a4b2","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/3xXvPBJ2NJ_uZgG.c_zzOQ--~B/aD01MTI7dz0xMDI0O2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/business-wire.com/3912c5832ea4ed32855cb10e0d53a4b2"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/geron-announces-positive-chmp-opinion-113600100.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["TD","BK4585","BK4139","BK4215","BK4566","EC","BK4599","BK4588","AST","CHMP","BK4156","MAA","BK4207","ALT","LU1878469433.USD","BK4201","GERN","BK4087"],"gpt_icon":0},{"id":"2491316965","title":"CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union","url":"https://stock-news.laohu8.com/highlight/detail?id=2491316965","media":"Business Wire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2491316965?lang=en_us&edition=fundamental","pubTime":"2024-12-13 14:00","pubTimestamp":1734069600,"startTime":"0","endTime":"0","summary":"Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease characterized by persistent itch and recurrent skin lesions, and affects approximately up to 40 million people in the European Union 1-4. Prurigo nodularis is a serious skin disease characterized by chronic itch, skin nodules covering large body areas, and poor sleep quality, which is estimated to affect up to 111 people per 100,000 in the EU5-10. Nemolizumab is a first-in-class monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.2 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis11-13. Prurigo nodularis is a serious skin condition characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality.5-7,10 The condition is underrecognized and underdiagnosed, and its prevalence is not well-","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/JdZCDsr3AFSxjWpIIOkIyw--~B/aD0yMDk7dz04MjM7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/business-wire.com/0fe6384bd7ef9918399c82acd69d1573","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/JdZCDsr3AFSxjWpIIOkIyw--~B/aD0yMDk7dz04MjM7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/business-wire.com/0fe6384bd7ef9918399c82acd69d1573"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/chmp-recommends-approval-galderma-nemolizumab-060000845.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4205","BK4233","GDERF","TCI","BK4200","BK4087","GALDY","BK4007","CHMP","TCS","BK4156"],"gpt_icon":0},{"id":"2485841796","title":"Positive Outlook for Formycon AG: CHMP Approval and Strategic Market Positioning Reinforce Buy Rating","url":"https://stock-news.laohu8.com/highlight/detail?id=2485841796","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2485841796?lang=en_us&edition=fundamental","pubTime":"2024-11-22 00:55","pubTimestamp":1732208128,"startTime":"0","endTime":"0","summary":"Formycon AG (FYB – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Yi Chen from H.C. Wainwri...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/positive-outlook-for-formycon-ag-chmp-approval-and-strategic-market-positioning-reinforce-buy-rating?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/positive-outlook-for-formycon-ag-chmp-approval-and-strategic-market-positioning-reinforce-buy-rating?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["CHMP","AG"],"gpt_icon":0},{"id":"2484928765","title":"CHMP Endorses AstraZeneca's Tagrisso for Expanded Use in NSCLC","url":"https://stock-news.laohu8.com/highlight/detail?id=2484928765","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484928765?lang=en_us&edition=fundamental","pubTime":"2024-11-19 21:23","pubTimestamp":1732022580,"startTime":"0","endTime":"0","summary":"AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use  recommended approving its blockbuster cancer drug Tagrisso for expanded use across a new setting in the non-small cell lung cancer  setting.The CHMP has recommended approving Tagrisso for treating adult patients with locally advanced, unresectable NSCLC with EGFR exon 19 deletions  or exon 21 L858R substitution  mutations, whose disease has not progressed during or following platinum-based chemoradiation therapy. The FDA approved this combination in September for a similar indication.This recommendation is based on data from the phase III LAURAstudy, which showed that treatment with Tagrisso reduced the risk of disease progression or death by 84% versus placebo. Patients treated with the drug experienced a median progression-free survival of 39.1 months compared with 5.6 months for patients in the placebo group.Tagrisso is currently approved in the EU for four indications, all across different sett","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/6pmiwRZRhtc7hxDNA3zxVQ--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/ef77d5a5eb4e72e4dd31ccfaf4ca4ccd","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/6pmiwRZRhtc7hxDNA3zxVQ--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/ef77d5a5eb4e72e4dd31ccfaf4ca4ccd"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/chmp-endorses-astrazenecas-tagrisso-expanded-132300129.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4196","BK4585","BK4007","CHMP","LU2456880835.USD","LU2236285917.USD","LU1829250122.USD","CSTL","BK4139","LU0320765992.SGD","BK4588","SPRO","BK4568","CTMX","LU2462157665.USD","LU0109394709.USD","BK4087","LU2417539215.USD","LU0889565916.HKD","AZN"],"gpt_icon":0},{"id":"2484578606","title":"AbbVie's Ovarian Cancer Drug Elahere Gets Approval in Europe","url":"https://stock-news.laohu8.com/highlight/detail?id=2484578606","media":"Zacks","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484578606?lang=en_us&edition=fundamental","pubTime":"2024-11-18 23:17","pubTimestamp":1731943020,"startTime":"0","endTime":"0","summary":"AbbVie ABBV announced that the European Commission  has granted marketing authorization to Elahere  for treating platinum-resistant ovarian cancer.The EC has approved Elahere for treating adult patients with folate receptor-alpha (FRα) positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatments.Following the approval, Elahere became the first and only FRα-directed antibody drug conjugate  approved specifically for patients with FRα positive, platinum-resistant ovarian cancer in the European Union.Elahere was granted full approval by the FDA for a similar indication in March 2024. The drug was initially approved for this indication under the accelerated pathway in 2022.Shares of AbbVie have gained 6.5% so far this year compared with the industry’s rise of 3.4%.Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, ANI Pharmaceuticals, Inc. ANIP and","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/J5PJq8rtkuiBcDVdnbD5LA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/dbd916198e87314e1ef238f8179e6227","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/J5PJq8rtkuiBcDVdnbD5LA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/dbd916198e87314e1ef238f8179e6227"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/abbvies-ovarian-cancer-drug-elahere-151700486.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["CHMP","BK4196","ADC","IE00BVYPNW00.USD","LU0234572021.USD","BK4534","LU2468319806.SGD","ANIP","LU1244550221.USD","BK4231","IE00BJT1NW94.SGD","LU1037948541.HKD","ABBV","LU0708994859.HKD","CSTL","LU0985320562.USD","LU1244550494.USD","IE00BVYPNV92.GBP","LU0456855351.SGD","LU0128525929.USD","BK4505","LU1718418525.SGD","BK4007","LU2237443622.USD","IE00B42XCP33.USD","LU1989772923.USD","SG9999011175.SGD","LU0965509101.SGD","LU1267930573.SGD","BK4585","LU0965509010.AUD","LU0820561909.HKD","BK4581","LU0861579265.USD","LU0689472784.USD","LU0256863811.USD","LU0234570918.USD","LU2023251221.USD","LU0965509283.SGD","IMCR","SG9999015978.USD","LU0310800379.SGD","IE00B4R5TH58.HKD","LU0417517546.SGD","LU2237443465.HKD","LU2347655156.SGD","SG9999003800.SGD","LU1244550577.SGD","LU0203345920.USD","LU1551013342.USD"],"gpt_icon":0},{"id":"2484567937","title":"CHMP Endorses J&J's Rybrevant-Lazcluze Combo for Use in NSCLC","url":"https://stock-news.laohu8.com/highlight/detail?id=2484567937","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484567937?lang=en_us&edition=fundamental","pubTime":"2024-11-18 20:42","pubTimestamp":1731933720,"startTime":"0","endTime":"0","summary":"The CHMP has recommended the Rybrevant-Lazcluze combination as a first-line treatment for adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions  or exon 21 L858R substitution  mutations. The FDA approved this combination in August for a similar indication.This recommendation is based on data from the phase III MARIPOSA study, which evaluated the Rybrevant-Lazcluze combo against AstraZeneca’s AZN blockbuster oncology drug Tagrisso in patients with the above indication.Data from the MARIPOSA study showed that treatment with the JNJ combination therapy reduced the risk of disease progression or death by 30% compared withAZN’s Tagrisso. Patients who took the combo achieved a median duration of response  that was nine months longer than those treated with the AstraZeneca drug.Year to date, J&J’s shares have moved down 1.8% against the industry’s 3.3% growth.J&J currently carries a Zacks Rank #3 .","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/oeK5rO4fDl1d34mN96F56A--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/f3f15a36f635cd8200884e1a968d4c3d","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/oeK5rO4fDl1d34mN96F56A--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/f3f15a36f635cd8200884e1a968d4c3d"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/chmp-endorses-j-js-rybrevant-124200522.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4585","IE00B42XCP33.USD","LU1244550494.USD","LU1023059063.AUD","LU1894683264.USD","LU0912757837.SGD","IE00B1BXHZ80.USD","LU1829250122.USD","BK4139","LU0795875086.SGD","LU1066051811.HKD","LU1929549753.HKD","IE00BJJMRZ35.SGD","SPRO","IE00B19Z3581.USD","BK4533","LU1261432733.SGD","CSTL","LU1585245621.USD","LU1066053197.SGD","LU1066051225.USD","JNJ","LU1244550577.SGD","LU2347655156.SGD","LU0234570918.USD","LU0345769631.USD","IE00BGHQF631.EUR","BK4196","BK4592","AZN","LU1732799900.SGD","BK4568","LU1032955483.USD","LU1074936037.SGD","IE000M9KFDE8.USD","LU1506573853.SGD","IE00B4R5TH58.HKD","LU0345770308.USD","IE0002141913.USD","LU1057294990.SGD","IE0002270589.USD","LU0466842654.USD","IE00BDGV0183.EUR","LU1935042991.SGD","LU1244550221.USD","BK4087","LU0203345920.USD","SG9999002232.USD","CHMP","LU0098860793.USD"],"gpt_icon":0},{"id":"2484623098","title":"AstraZeneca’s Tagrisso recommended for approval in EU by CHMP for certain NSCLC","url":"https://stock-news.laohu8.com/highlight/detail?id=2484623098","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484623098?lang=en_us&edition=fundamental","pubTime":"2024-11-18 19:35","pubTimestamp":1731929744,"startTime":"0","endTime":"0","summary":"AstraZeneca’s (AZN) Tagrisso has been recommended for approval in the European Union for the treatment of adult patients with locally advanced, unr...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/astrazenecas-tagrisso-recommended-for-approval-in-eu-by-chmp-for-certain-nsclc?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/astrazenecas-tagrisso-recommended-for-approval-in-eu-by-chmp-for-certain-nsclc?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["LU1829250122.USD","LU2417539215.USD","LU0109394709.USD","BK4568","BK4585","LU0889565916.HKD","BK4087","BK4007","LU2236285917.USD","LU0320765992.SGD","BK4588","CHMP","LU2462157665.USD","BK4156","AZN","LU2456880835.USD"],"gpt_icon":0},{"id":"2483260305","title":"Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe","url":"https://stock-news.laohu8.com/highlight/detail?id=2483260305","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483260305?lang=en_us&edition=fundamental","pubTime":"2024-11-15 22:04","pubTimestamp":1731679440,"startTime":"0","endTime":"0","summary":"Biogen Inc.’s BIIB Japan-based partner, Eisai announced that the European Medicines Agency’s  Committee for Medicinal Products for Human Use  has rendered a positive opinion recommending marketing approval for Leqembi  for early Alzheimer’s disease.The CHMP recommended marketing approval for Leqembi as a treatment of adult patients with early Alzheimer’s disease who are apolipoprotein E ε4  non-carriers or heterozygotes with confirmed amyloid pathology in Europe.A final decision from the European Commission is expected within 67 days of receipt of the CHMP opinion.Shares of Biogen have plunged 36.3% year to date compared with the industry’s decline of 4.5%.Meanwhile, the FDA accepted Eisai’s supplemental biologics license application  seeking approval for a maintenance intravenous  dosing version of Leqembi for the treatment of early Alzheimer's disease in June.A decision from the regulatory body for the maintenance IV dosing version of Leqembi is expected on Jan. 25, 2025.Though the 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Myers Squibb Receives Positive CHMP Opinion For Opdivo (Nivolumab) Plus Yervoy (Ipilimumab) For The First-Line Treatment Of Adult Patients With Microsatellite Instability–High Or Mismatch Repair Deficient Metastatic Colorectal Cancer","url":"https://stock-news.laohu8.com/highlight/detail?id=2483375746","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483375746?lang=en_us&edition=fundamental","pubTime":"2024-11-15 21:30","pubTimestamp":1731677444,"startTime":"0","endTime":"0","summary":"Nov 15  - Bristol-Myers Squibb Co   :   * BRISTOL MYERS SQUIBB RECEIVES POSITIVE CHMP OPINION FOR OPDIVO  PLUS YERVOY  FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH MICROSATELLITE INSTABILITY–HIGH OR MISMATCH REPAIR DEFICIENT METASTATIC COLORECTAL CANCERSource text:    Further company coverage:    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